Advocacy group to rally for prostate cancer therapy, FDA reform

A cancer patient advocacy group said it will rally at FDA headquarters this month to ask FDA to reconsider its “flawed” decision on sipuleucel-T (Provenge), a form of immunotherapy under investigation for the treatment of late-stage prostate cancer.

Sipuleucel-T has already been endorsed by an FDA-appointed panel of experts that unanimously determined it to be safe for its intended use, according to A Right to Live, an advocacy group formed to promote cancer patients' right to live through access to potentially life-saving therapies. The panel also voted 13-4 in favor of the “substantial evidence of efficacy” of the drug, the group said.

In May, FDA said that either a positive interim or final analysis of survival would address the agency's request for the submission of additional clinical data to support the efficacy claim made for sipuleucel-T. Interim survival results are anticipated in 2008.

"There has never been such an incredible, irrational, and unjustifiable denial of the rights of dying patients by such a dysfunctional agency," said Scott Riccio of A Right to Live. "We're not asking for the FDA to forego scientific review, we're asking the agency to catch up to the science that already exists and use it to approve and monitor these life-saving new therapies while patients and their doctors get informed access to them."

The rally, billed as "A Right To Live Day," will be held at 10 a.m. on Sept. 18, at the FDA offices in Rockville, MD. Riccio told Urology Times that a small fund was available to help defray costs for any cancer patient interested in attending the rally. For more information, visit www.arighttolive.com.